Senior Quality Specialist General Medicine VIE Contract

BioSpace; Framingham (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Sanofi is seeking a Senior Quality Specialist General Medicine for the VIE program in Framingham, MA. You will ensure cGMP compliance for subcontracted products and collaborate with NA manufacturing, contract manufacturers, and global sites.

The role emphasizes quality systems, regulatory submissions, and cross-functional teamwork with MSAT, regulatory, and supply chain to maintain product quality and continuous improvement.

Qualifications

• 1–3 years in Pharmaceutical Operations or Quality Operations applying cGMP.
• Experience with third-party manufacturing Quality and Regulatory function.

Responsibilities

• Ensures Quality and Regulatory compliance of subcontracted products per cGMPs and Sanofi directives.
• Manages quality system activities with contractors including complaints, deviations, change controls, non-conformities, and release/disposition.
• Strengthens Quality and Regulatory strategy during crises and tracks action plan implementation.
• Supports NA External Manufacturing Audit program; conducts contractor audits and manages CAPAs.
• Projects include new product launches, onboarding/offboarding of subcontractors and products.
• Identifies and resolves quality issues impacting cGMP compliance and regulatory filings.
• Develops and negotiates subcontractor Quality Agreements and provides quality guidance to subcontractors.

Skills

cGMP knowledge

Quality Assurance

Regulatory liaison

Audit coordination

Contract manufacturing

Project management

Communication skills

Education

Bachelor's degree in Science or related field

Job description

Senior Quality Specialist General Medicine - VIE Contract

• Location: United States of America, Framingham
• Target start date: 01/01/2027

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered.

About The Job

As Senior Quality Specialist General Medicine VIE within our Quality System team, youll interact extensively with North American manufacturing/packaging sites, contract manufacturers, and with sites inside and outside the US which manufacture products that include all dosage forms for numerous global markets. You will work closely with the contractors, quality team, supply chain, Manufacturing Science and Technology (MSAT), regulatory, and other appropriate groups to ensure compliance and continuous improvement in quality functions to ensure compliance with Current Good Manufacturing Practices (cGMPs) and regulatory submissions. Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster. Ready to get started?

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main Responsibilities

• Ensures the Quality and Regulatory compliance of products subcontracted to external entities on behalf of Sanofi in accordance with cGMPs and Sanofi Quality directives.
• Ensures the efficiency of Quality System implemented between Sanofi and the sub-contractors ensuring relevant management for complaints, deviations, change controls, non-conformities, or any activity aiming to ensure the production, the control, and the release/disposition of products accordingly with Quality, regulatory, and procedural requirements.
• Strengthens the Quality and Regulatory strategy particularly during crisis management and verify the implementation of the relevant action plans.
• Support the External Manufacturing North America Audit program by working with and conducting contractor audits to assure compliance with Sanofi Quality Directives, (cGMPs, and regulatory filings. Leads or participates in the subcontractors audits and managers the CAPAs that follow.
• Supports and manage projects assigned such as new product launch, onboarding/offboarding or subcontractors and products.
• Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filing, or other risks to Sanofi products.
• Develops and negotiates the subcontractors Quality Agreements defining the responsibilities between both parties and provides quality advice to subcontractors.

About you

• 1-3 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
• Experience in third party manufacturing Quality and Regulatory function and/or same plat experience.

Soft And Technical Skills

• Excellent oral and written communication skills in cGMP documentation
• Interpersonal skills to interface with suppliers and customers to develop privileged communications and relationships.
• Excellent teamwork and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects.
• Effectively communicate at all levels of associates in the Sanofi organization (from operator to vice president) or supplier and customer at all levels
• The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries, especially those related to handling product complaints and the associated regulations.
• Thorough knowledge of GMP's and regulatory requirements.
• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations.
• Project management skills.

Education

• Bachelors degree in Science or related field.

Languages

• Fluent English (written & verbal).

Why choose us?

• Be part of a pioneering biopharma company where patient insights shape drug development.
• Work at the forefront of AI-powered science that accelerates discovery and improves outcomes.
• Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply.

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow. Sanofis Work Abroad Program, iMove, offers jobs‑assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.